RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC26H23N7O2

InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N

CAS Registry1420477-60-6

164

Clinical Trials associated with Acalabrutinib

NCT07257055

/ Not yet recruitingPhase 2IIT

Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study

to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.

Start Date12 May 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07024706

/ Not yet recruitingPhase 2

The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab

This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.

Start Date30 Jan 2026

Sponsor / Collaborator

AstraZeneca PLC

[+2]

NCT07283965

/ Not yet recruitingNot ApplicableIIT

Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

Background. Zanubrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.
Objectives. Our aim was to examine the risk of developing incident AF with zanubrutinib exposure compared with acalabrutinib exposure.
Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.

Start Date22 Dec 2025

Sponsor / Collaborator

Caen University Hospital

100 Clinical Results associated with Acalabrutinib

100 Translational Medicine associated with Acalabrutinib

100 Patents (Medical) associated with Acalabrutinib

794

Literatures (Medical) associated with Acalabrutinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Prolonged progression-free survival with zanubrutinib in relapsed/refractory CLL: an indirect treatment comparison versus other BTK inhibitors using multilevel network meta-regression

Article

Author: Xu, Sheng ; Bouwmeester, Walter ; Yang, Keri ; Mohseninejad, Leyla ; Jevdjevic, Milica ; Shadman, Mazyar ; Jansen, Jeroen P. ; Williams, Rhys

BACKGROUND:

Bruton tyrosine kinase inhibitors (BTKis) are therapeutic agents for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Previous indirect treatment comparisons are limited in simultaneously comparing multiple interventions and adjusting for population differences. This study aimed to use a more rigorous approach called multilevel network meta-regression (ML-NMR) to estimate the relative treatment effects of zanubrutinib compared to acalabrutinib and ibrutinib in two target populations: a general R/R CLL population similar to the phase 3 ALPINE trial's intention-to-treat (ITT) population, and a high-risk population with del(17p) and/or del(11q), similar to the ITT population of the phase 3 ELEVATE-RR trial.

METHODS:

The ML-NMR was conducted using data from three phase 3 randomized controlled trials: ALPINE (N = 652), ELEVATE-RR (N = 533), and ASCEND (N = 310). Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. The ML-NMR integrated individual patient data from ALPINE with aggregate data from the other trials, incorporating important effect modifiers to estimate relative treatment effects for the target populations.

RESULTS:

In the general R/R CLL population, zanubrutinib showed an improved PFS compared to ibrutinib (HR = 0.67, 95% Credible Interval [CrI] = 0.52-0.87) and acalabrutinib (HR = 0.57, 95% CrI = 0.34-0.95). In the high-risk population, zanubrutinib maintained its PFS advantage over ibrutinib and acalabrutinib. OS was similar across BTKis in both populations, with wide CrIs that included an estimate of no difference between treatments.

CONCLUSION:

This ML-NMR suggests that zanubrutinib offers improved PFS compared to ibrutinib and acalabrutinib in both general and high-risk R/R CLL populations. OS results were uncertain due to limited follow-up.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

A real-world study evaluating drug tolerability and health care resource use with acalabrutinib vs ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

Article

Author: Wahlstrom, Svea K. ; Blau, Sibel ; Peevyhouse, Aaron ; Thompson, Samantha L. ; Dietz, Lee Ann ; Teschemaker, Anna ; Dranitsaris, George ; Huynh, Chanh ; Neuhalfen, Heather ; Narkhede, Mayur ; Shetty, Vikram ; Ermann, Daniel

BACKGROUND AND AIM:

Bruton tyrosine kinase inhibitors (BTKis) are the standard of care for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Ibrutinib and acalabrutinib are two commonly used BTKis, though hypertension (HTN) and other cardiovascular medical events of interest (CV MEOIs) can impact treatment tolerability and long-term use. This study compared cardiovascular safety and health care resource use (HCRU) of acalabrutinib versus ibrutinib monotherapy for R/R CLL/SLL in real-world community practice.

METHODS:

This retrospective comparative study included 270 RR CLL/SLL patients (90 acalabrutinib; 180 ibrutinib) treated from January 2017 through December 2023 across the ONCare Alliance Network, comprising 30 US community hematology practices. Endpoints included new or worsening of existing HTN, development of CV MEOIs, and treatment discontinuation due to adverse events. HCRU metrics consisted of emergency department visits, hospital admissions, length of stay, specialist consultations, and related medical procedures. Propensity score weighted multivariable logistic regression was used for the comparative analysis on the tolerability endpoints.

RESULTS:

At a median follow-up of 33 months, patients treated with acalabrutinib had significantly fewer HTN events (OR = 0.27, 95% CI = 0.074-0.98; p = .046) and adverse events leading to treatment discontinuation (OR = 0.39, 95% CI = 0.20-0.73; p = .002) compared to those on ibrutinib. Hospital admission rates for MEOIs were lower in the acalabrutinib group (0.20 vs. 0.24 per patient), with a shorter median length of stay (3.0 vs. 6.0 days). Additionally, acalabrutinib patients had fewer specialist consultations (0.11 vs. 0.22 per patient) and associated medical procedures (0.11 vs. 0.18 per patient).

CONCLUSIONS:

In R/R CLL/SLL, acalabrutinib demonstrated a more favorable cardiovascular safety profile than ibrutinib, with fewer HTN events and CV MEOIs. This translated into reduced hospital admissions and lower HCRU, supporting acalabrutinib as a potentially better tolerated long-term treatment option in community practice.

10 Mar 2026·Blood Advances

Real-world comparative effectiveness of Bruton tyrosine kinase inhibitors in relapsed/refractory mantle cell lymphoma

Article

Author: Maglinte, Gregory A. ; Pierre, Amy ; Phillips, Tycel ; Wang, Yucai ; Wang, Jingru ; Di, Mengyang ; Seymour, Erlene K. ; Miller, Taavy A.

Abstract:

This real-world retrospective cohort study evaluated utilization and comparative effectiveness of covalent Bruton tyrosine kinase inhibitor (cBTKi) monotherapies in relapsed/refractory mantle cell lymphoma (R/R MCL) from electronic health records in the United States. Adults with R/R MCL who received second- or third-line (2L/3L) zanubrutinib, acalabrutinib, or ibrutinib monotherapy, on or after 1 January 2018, were included. Inverse probability of treatment weighting was used in adjusted Cox models to compare real-world time-to-next treatment (rwTTNT) and overall survival (rwOS). Among 698 patients who received 2L/3L cBTKi monotherapy, 49%, 32%, and 19% received acalabrutinib, ibrutinib, and zanubrutinib, respectively. Unadjusted analyses showed median rwTTNT for 2L zanubrutinib, acalabrutinib, and ibrutinib was 14.5 (95% confidence interval [CI], 11.0-23.2), 12.8 (95% CI, 10.5-15.6), and 10.3 (95% CI, 7.6-13.7) months, and median rwOS was 26.4 (95% CI, 23.2 to not reached [NR]), 29.2 (95% CI, 22.9-38.1), and 29.3 (95% CI, 21.8-41.6) months, respectively. Median rwTTNT for 3L zanubrutinib, acalabrutinib, and ibrutinib was 21.1 (95% CI, 3.9 to NR), 9.2 (95% CI, 6.8-14.7), and 9.6 (95% CI, 4.8-18.0) months, and median rwOS was NR (95% CI, 27.3 to NR), 27.4 (95% CI, 15.1-42.2), and 27.0 (95% CI, 15.6 to NR) months, respectively. Adjusted models in the 2L/3L cohorts combined showed numerically longer rwTTNT and statistically significantly longer rwOS for zanubrutinib vs ibrutinib (hazard ratio, 0.63; 95% CI, 0.42-0.96), and trends for improved rwTTNT and rwOS for zanubrutinib over acalabrutinib. Toxicity was a frequent reason for changing to another cBTKi. These findings suggest potential improvements in rwTTNT and rwOS with the use of second- and next-generation cBTKis for R/R MCL from 2018 and beyond.

270

News (Medical) associated with Acalabrutinib

23 Mar 2026

·www.biospace.com

HUTCHMED Initiates Phase III Trial of HMPL-760 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma in China

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 23, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a registrational Phase III clinical trial of HMPL-760 in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with relapsed/refractory diffuse large B-cell lymphoma (“DLBCL”) in China. The first patient received the first dose on March 20, 2026. DLBCL is the most common form of aggressive non-Hodgkin lymphoma (“NHL”) worldwide, accounting for approximately 40% of all NHL cases in China. 1 In 2022, approximately 81,000 new cases of NHL are estimated to have been diagnosed in China. 2 Bruton’s tyrosine kinase (“BTK”) is considered a validated target for drugs that aim to treat certain hematological cancers. HMPL-760 is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK. The trial is a randomized, double-blind, positive controlled Phase III study to evaluate the efficacy, safety, and pharmacokinetics (“PK”) of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in DLBCL patients who are relapsed or refractory after prior treatment with first-line systemic chemotherapy, immunotherapy, or immunochemotherapy regimens and ineligible for transplantation. Primary outcome measures include investigator-assessed progression-free survival (“PFS”) and overall survival (“OS”). Secondary outcome measures include independent review committee (“IRC”)-assessed PFS, IRC- and investigator-assessed objective response rate (“ORR”), complete response rate (“CRR”), duration of response (DoR), clinical benefit rate (CBR), time to response (TTR), safety and PK characteristics. Additional details may be found at clinicaltrials.gov, using identifier NCT07409428 . This registrational trial plans to enroll approximately 240 patients and is being led by principal investigator Professor Weili Zhao, Vice President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Institute of Hematology. About HMPL-760 HMPL-760 is an investigational, non-covalent, third generation BTK inhibitor. It is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK. BTK C481S mutation plays an important role in resistance to certain BTK inhibitors . 3 , 4 A randomized, double-blind Phase II study ( NCT06601504 ) evaluating HMPL-760 in combination with R-GemOx in patients with relapsed/refractory DLBCL has demonstrated encouraging improvements in ORR, CRR, PFS and OS compared to R-GemOx alone, with a manageable safety pro no unexpected safety signal. These encouraging results supported the initiation of this registrational Phase III trial. HUTCHMED currently retains all rights to HMPL-760 worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-760 for the treatment of DLBCL and the further development of HMPL-760 in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of HMPL-760 for the treatment of DLBCL or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety pro HMPL-760, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-760 and the timing of these events. In addition, as certain studies rely on the use of other drug products such as R-GemOx as combination therapeutics with HMPL-760, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 689 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000 _____________________ 1 Li XQ, Li GD, Gao ZF, et al. Distribution pattern of lymphoma subtypes in China: A nationwide multicenter study of 10002 cases. J Diagn Concepts Pract . 2012; 11(02):111-115. 2 The Global Cancer Observatory, China fact sheet. . Accessed December 3, 2025. 3 Woyach JA, Ruppert AS, Guinn D, et al. BTKC 481S -Mediated Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol . 2017;35(13):1437-1443. doi: 10.1200/JCO.2016.70.2282 . 4 Woyach JA, Huang Y, Rogers K, et al. Resistance to Acalabrutinib in CLL is Mediated Primarily by BTK Mutations. Blood. 2019;134 (Supplement_1): 504. doi: 10.1182/blood-2019-127674 .

Phase 2Phase 3Drug ApprovalImmunotherapy

18 Mar 2026

·www.biospace.com

Ascentage Pharma to Present Data From Four Preclinical Studies In Its Innovative Pipeline at American Association of Cancer Research (AACR) Annual Meeting 2026

ROCKVILLE, Md. and SUZHOU, China, March 17, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that four abstracts highlighting the latest preclinical results from its pipeline programs have been selected for poster presentations at the American Association of Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026, in San Diego, CA, USA. The data to be presented encompasses three of the Company’s novel drug candidates: BCR-ABL tyrosine kinase inhibitor Olverembatinib (HQP1351), FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and PRC2/EED inhibitor APG-5918. The AACR Annual Meeting 2026 is the critical driver of progress against cancer, the place where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share and discuss the latest breakthroughs. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting showcases cutting-edge cancer science and medicine. The four preclinical abstracts from Ascentage Pharma include: Multitarget kinase inhibitor olverembatinib (HQP1351) is efficacious and synergizes with chemotherapy in preclinical models of endometrial carcinoma (EC) Abstract#: 4583 Poster Session Category: Experimental and Molecular Therapeutics Session Title: Novel Antitumor Agents 2 Time: Tuesday, April 21, 2026, 9:00 AM – 12:00 PM PDT Multikinase inhibitor olverembatinib (HQP1351) is efficacious and synergizes with BTK inhibitor acalabrutinib in mantle cell lymphoma (MCL) preclinical models Abstract#: 5875 Poster Session Category: Experimental and Molecular Therapeutics Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PDT FAK inhibition by APG-2449 enhances the antitumor activity of MAPK pathway blockade in BRAF V600E-mutant tumor models Abstract#: 1858 Poster Session Category: Experimental and Molecular Therapeutics Session Title: Targeting Drug Resistance 1: Apoptosis and Autophagy Time: Monday, April 20, 2026, 9:00 AM – 12:00 PM PDT Embryonic ectoderm development (EED) inhibitor APG-5918 synergizes with topoisomerase I inhibitors in preclinical small-cell lung cancer (SCLC) models through epigenetic priming of chemosensitivity Abstract#: 4500 Poster Session Category: Experimental and Molecular Therapeutics Session Title: Epigenetic Modulators 1 Time: Tuesday, April 21, 2026, 9:00 AM – 12:00 PM PDT *Olverembatinib, APG-2449, and APG-5918 are currently under investigation and have not been approved by the U.S. FDA. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors. The lead asset, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of Olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including BTK inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia (AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the U.S. FDA, the EMA of the EU, and China CDE. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor Relations: Yuly Chen, Senior Investor Relations Director Ascentage Pharma IR@ascentage.com +86 512 85557777 +1 (301) 792-5658 Stephanie Carrington ICR Healthcare AscentageIR@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare AscentagePR@icrhealthcare.com +1 (646) 866-4012

Phase 3Drug ApprovalAACR

02 Mar 2026

·www.prnewswire.com

Jaypirca® (Pirtobrutinib) Approved in China for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

SAN FRANCISCO and SUZHOU, China, March 1, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announces the non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor. Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).[1],[2] Pirtobrutinib received approval from the U.S. FDA in January 2023 as a non‑covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton's tyrosine kinase (BTK) inhibitor. The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL‑321 study. BRUIN CLL‑321 is the world's first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator's choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab). The results demonstrated that pirtobrutinib significantly prolonged median progression‑free survival (PFS) compared with the investigator's choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment‑related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.[3] Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL ‑ 321 study in China, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, "BTK inhibitors have become the preferred first‑ or second‑line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis. Studies have shown that the median overall survival for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months.[4] Therefore, there is an urgent clinical need for new treatment. As a next‑generation, non‑covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL. The BRUIN CLL‑321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long‑term disease management in the future." Dr. Li Wang, Lilly Corporate Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, states, "The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option. Supported by the efficacy and safety demonstrated in the BRUIN CLL‑321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting‑edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival. This is our enduring commitment to patients in China." Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation. We will fully leverage Innovent's leading brand presence and commercialization capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need." About BRUIN CLL-321 BRUIN CLL-321 is a Phase 3, randomized, open-label study of Jaypirca versus investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in covalent Bruton tyrosine kinase (BTK) inhibitor pre-treated patients with relapsed and refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial enrolled 238 patients, who were randomized 1:1 to receive Jaypirca (200 mg orally, once daily) or investigator's choice of either IdelaR or BR per labeled doses. This trial's primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC). Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO). About Jaypirca (pirtobrutinib) Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[2] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[5],[6] In China, pirtobrutinib was developed by Eli Lilly and Company and is commercialized in mainland China by Innovent Biologics. About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes.[7] In China, chronic lymphocytic leukemia (CLL) represents approximately 6%–7% of non-Hodgkin lymphoma cases.[8] SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells. In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes.[7] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References Jaypirca. Prescribing Information. Lilly USA, LLC. Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5 Sharman JP,et al.2024 ASH Oral presentation #886 Woyach JA, Ruppert AS, Guinn D, et al. BTKC481S-mediated resistance to ibrutinib in chronic lymphocytic leukemia. J Clin Oncol. 2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282 Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1 Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7 Mukkamalla SKR, Taneja A, Malipeddi D, et al. Chronic Lymphocytic Leukemia. [Updated Feb 18, 2023]. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Available from: CACA. 中国肿瘤整合诊治指南（CACA）- 白血病 2022. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 3Clinical ResultDrug ApprovalPhase 2CSCO

100 Deals associated with Acalabrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10893	Acalabrutinib	L01XE51	DB11703

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	European Union	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Iceland	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Liechtenstein	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Norway	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	European Union	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Iceland	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Liechtenstein	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Norway	AstraZeneca AB	27 May 2025
Small Lymphocytic Lymphoma	United States	AstraZeneca UK Ltd.	21 Nov 2019
Chronic Lymphocytic Leukemia	Canada	AstraZeneca Canada, Inc.	02 Oct 2019
Mantle-Cell Lymphoma	United States	AstraZeneca UK Ltd.	31 Oct 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ALK positive large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Mediastinal large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Recurrent Chronic Lymphoid Leukemia	Phase 3	Germany	AstraZeneca PLC	19 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 3	Austria	AstraZeneca PLC	07 Oct 2020
CD20 Positive B-Cell Chronic Lymphocytic Leukemia	Phase 3	United States	Acerta Pharma BV	02 Feb 2017
CD20 Positive B-Cell Chronic Lymphocytic Leukemia	Phase 3	Australia	Acerta Pharma BV	02 Feb 2017
CD20 Positive B-Cell Chronic Lymphocytic Leukemia	Phase 3	Austria	Acerta Pharma BV	02 Feb 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04855695 (AACR2026)	Phase 1/2	Mantle-Cell Lymphoma	9	ObinutuzumabAcalabrutinibVenetoclaxnib + ObinutuzumabAcalabrutinibVenetoclax + ObinutuzumabAcalabrutinibVenetoclaxab	jktjdsuwdo(dzvsgzfqun) = zikoytlkpc tmzjtnvktm (ujmozmxbkg )	Positive	20 Apr 2026
				Obinutuzumab (Durable Response)	jktjdsuwdo(dzvsgzfqun) = novewhchjo tmzjtnvktm (ujmozmxbkg )
NCT04198922 (Tandem Meetings ASTCT and CIBMTR2026)	Phase 2	Steroid Refractory Graft Versus Host Disease	50	Acalabrutinib 100mg	sppqmcbcit(myoohppuco) = iglyrjuwqb ocnupkbxwi (jyfjanxrlg, 53.4 - 81.8) View more	Positive	04 Feb 2026
NCT05583149 (CTgov)	Phase 2	High grade B-cell lymphoma \| Follicular Lymphoma \| T-cell/histiocyte rich large B-cell lymphoma ... View more	28	fludarabine+cyclophosphamide+Acalabrutinib+LISOCABTAGENE MARALEUCEL	chncythpej = cuaaavmivp uyhdoujqir (nooyghdxau, dltbaqeoiq - wlzpjcvnms) View more	-	29 Jan 2026
ACCRU-LY-1804 (ASH2025)	Phase 2	Mantle-Cell Lymphoma First line	41	CARiBOU (ACCRU-LY-1804)	ewtilxsqzb(sxghzyjzsv) = hzvqtmgkaj lqbhblyltt (dneofzctkw, 67.9 - 92.9) View more	Positive	06 Dec 2025
ALTAMIRA (ASH2025)	Phase 2	Mantle-Cell Lymphoma First line ADAMTS8	171	Rituximab+Acalabrutinib	kjqcuxyied(fnvhyygmsk) = szgtabwjtj pdznasvwos (psaoxmljej ) View more	Positive	06 Dec 2025
				chemoimmunotherapy	kjqcuxyied(fnvhyygmsk) = uaevlbdnrz pdznasvwos (psaoxmljej ) View more
NCT02972840 (ECHO, ASH2025)	Phase 3	Mantle-Cell Lymphoma First line	298	ABR (acalabrutinib+bendamustine+rituximab)	fcuileeqwk(qdfstcaora) = mikcaosblk dnvnlpyssf (xhztsoxqwd ) View more	Positive	06 Dec 2025
				PBR (placebo+bendamustine+rituximab)	fcuileeqwk(qdfstcaora) = tcmehujzfl dnvnlpyssf (xhztsoxqwd ) View more
NCT02972840 (ECHO, ASH2025)	Phase 3	Mantle-Cell Lymphoma TP53 mutation	598	Acalabrutinib plus bendamustine-rituximab (ABR)	pazmekgdof(aklxjkeoit) = nmpqmtuhgx oqykbkgows (xobvljivxk )	Positive	06 Dec 2025
				Placebo plus BR (PBR)	pazmekgdof(aklxjkeoit) = tzqwhtwgof oqykbkgows (xobvljivxk )
ASH2025	Not Applicable	Chronic Lymphocytic Leukemia First line	2,264	Acalabrutinib	ahiihxebrs(utplawodkf) = including pneumonia (6.63% vs 5.92%, p = 0.4880; RR: 1.119, 95% CI: 0.814 to 1.54), sepsis (4.51% vs 3.53%, p = 0.2392; RR: 1.275, 95% CI: 0.85 to 1.913), GI symptoms (6.98% vs 5.83%, p = 0.2645; RR: 1.197, 95% CI: 0.872 to 1.699), and atrial fibrillation/flutter (7.98% vs 7.18%, p = 0.4741; RR: 1.11, 95% CI: 0.833 to 1.483), was slightly higher with acalabrutinib, though differences were not statistically significant between cohorts. Rates of headache (RD: 0.297, p = 0.6955; RR: 1.11; 95% CI: 0.67 to 1.82), neutropenia/neutropenic fever (RD: 1.237, p = 0.1442; RR: 1.341, 95% CI: 0.903 to 1.993) and thrombocytopenia (RD: -0.618%, p = 0.6716; RR: 0.957, 95% CI: 0.78 to 1.174) did not differ significantly. fdltjjqszr (crcxcsvtjm ) View more	Positive	06 Dec 2025
				Zanubrutinib
ASH2025	Not Applicable	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	136	zanubrutinib	ljqwcuwhhe(xxlglijocg) = xdqfssolaw dsxuunohuw (vqxjwfjanl ) View more	Positive	06 Dec 2025
				acalabrutinib	ljqwcuwhhe(xxlglijocg) = fjeyjydnoa dsxuunohuw (vqxjwfjanl ) View more
ASH2025	Not Applicable	Mantle-Cell Lymphoma First line	802	Acalabrutinib-based combination regimens	xmfdcllybp(nsloikxnxo) = umgwxcrbhd sqawpuxzem (tiqkqdzwte, 68.44 - 87.29) View more	Positive	06 Dec 2025

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis